Debulking From Within: A Steerable Needle for Intracerebral Hemorrhage Aspiration

从内部减灭：用于脑出血抽吸的可操纵针

• 批准号: 8934206
• 负责人: Michael Ian Miga
• 金额: $ 17.44万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8934206
• 关键词: Algorithms; Animal Model; Animals; Biopsy; Blood; Body Fluids; Brain; Brain Injuries; Cannulas; Catheters; Cerebral hemisphere hemorrhage; Cerebrospinal Fluid; Clinical; Clinical Research; Coagulation Process; Devices; Diuretics; Effectiveness; Elasticity; Elements; Employee Strikes; Excision; Exploratory/Developmental Grant; Family suidae; Feedback; Funding; Future; Gelatin; Geometry; Goals; Health; Hematoma; Hemorrhage; Human; Image; Image-Guided Surgery; Incidence; Infusion Pumps; Intervention; Intracerebral Pressures; Lead; Lesion; Location; Mechanics; Modeling; Motion; Needles; Operative Surgical Procedures; Outcome; Patient observation; Patients; Pilot Projects; Problem Solving; Procedures; Research; Research Personnel; Risk; Robot; Rotation; Safety; Scanning; Series; Severities; Site; Solid; Surgical Decompression; System; Testing; Tissue Model; Tissues; Tumor Debulking; Visit; X-Ray Computed Tomography; base; biomechanical model; brain surgery; brain tissue; computer science; contrast enhanced; cost; design; design and construction; high reward; high risk; image guided; improved; interstitial; minimally invasive; mortality; multidisciplinary; neurosurgery; novel; novel strategies; pressure; prevent; prototype; research study; success; surgical research; theories

DESCRIPTION (provided by applicant): The objective of this proposal is to design, construct, and evaluate a steerable needle to debulk intracerebral hemorrhages (ICH) less invasively, from within. This is motivated by the fact that 1 in 50 people will have an ICH in their lifetime, with 40% mortality [50] regardless of whether surgical decompression is attempted. Despite its ability to decompress at-risk tissue, one reason surgery does not produce better overall clinical outcomes may be because of the large volume of healthy brain tissue disrupted simply to access the surgical site. To provide a means of achieving decompression more safely, we propose to create a system capable of debulking the hematoma that results from an ICH without wide exposure, through a needle-sized entry path. Our new steerable needle system will debulk the hematoma from within using a superelastic, precurved aspiration cannula that is deployed within the hematoma through a straight outer needle. The tip of this aspiration cannula is maneuvered within the hematoma by coordinated linear motion and axial rotation of both needle and cannula. The aims of this project involve integrating steerable needle hardware with computed tomography (CT) guidance and use of a deformation model to minimize the number of CT images required, and a demonstration of the system's effectiveness in a porcine model. To achieve these aims, this project brings together a multidisciplinary team combining expertise in neurosurgery (Co-I Weaver), electromechanical design of surgical devices (PI Webster), biomechanical modeling (PI Miga), computer science (Co-I Burgner), surgical research including animal studies (Co-I Williams), and image-guided surgery (all investigators). The endpoint of this R21 project will be a successful demonstration of the complete system in an animal model, which will pave the way for future R01-funded human clinical studies.

描述（由申请人提供）：该提案的目的是设计，构建和评估可通行的针头，以从内部降低脑内出血（ICH）。这是由于这一事实是，其中有50人将在他们的一生中拥有ICH，而死亡率为40％[50]，而不管是否尝试过手术减压。尽管能够对高危组织进行解压缩，但一个原因是手术并没有产生更好的整体临床结果，这可能是因为仅仅可以进入手术部位而受到大量健康脑组织的破坏。为了提供一种更安全地实现减压的方法，我们建议创建一个能够通过针大小的入口路径来缓解无需大量暴露而导致的血肿的系统。我们的新可进入的针头系统将使用超弹性的抽吸套管从内部降低血肿，该套管通过直立的外针部署在血肿中。该抽吸套管的尖端通过针对针和套管的线性运动和轴向旋转而在血肿内操纵。该项目的目的涉及将可进行的针硬件与计算机断层扫描（CT）指导和使用变形模型的使用，以最大程度地减少所需的CT图像数量，并在猪模型中证明系统的有效性。为了实现这些目的，该项目汇集了一个多学科团队，结合了神经外科（CO-I WEAVER），手术器械的机电设计（PI WebSter），生物力学建模（PI MIGA），计算机科学（CO-I BURGNER），手术研究（包括动物研究）（CO-I Williams和Image Bressed）（CO-I Burger）（CO-I Burgner）和图像研究。该R21项目的终点将成功证明动物模型中的完整系统，这将为未来的R01资助的人类临床研究铺平道路。